Date: 2013-06-03
Type of information: Development agreement
Compound: MOR103
Company: Morphosys (Germany) GSK (UK)
Therapeutic area: Autoimmune diseases – Inflammatory diseases - Rheumatic diseases - Neurodegenerative diseases
Type agreement: development
licensing
commercialisation
Action mechanism: monoclonal antibody. MOR103 is a fully human monoclonal antibody directed towards human GM-CSF, a cytokine that leads to activation and proliferation of immune cells causing inflammation. Preclinical studies have shown that MOR103 neutralizes the biological function of human GM-CSF and significantly reduces inflammation by blocking its interaction with cell surface receptors of inflammatory cells, thus inhibiting their activation. These studies suggest that GM-CSF is involved in the pathogenesis of autoimmune diseases such as rheumatoid arthritis and multiple sclerosis.
Disease: rheumatoid arthritis, multiple sclerosis
Details: * On June 3, 2013, MorphoSys has announced that the company has entered into a global agreement with GSK to develop and commercialize MOR103, a HuCAL-derived antibody against GM-CSF,which has concluded Phase 1/2 development in mild to moderate rheumatoid arthritis. MOR103 has concluded a Phase 1 study in healthy volunteers and a Phase 1/2 clinical trial in mild to moderate rheumatoid arthritis patients. Additionally, MOR103 is currently being evaluated in a Phase 1b dose-escalation safety study in multiple sclerosis.
Financial terms: Under the terms of the agreement, GSK will assume responsibility for all subsequent development and commercialization of MOR103. As part of the agreement, MorphoSys receives an immediate upfront payment of€22.5 million. On achievement of certain developmental, regulatory, commercial and sales-based milestones, MorphoSys would be eligible to receive additional payments from GSK of up to€423 million, in addition to tiered, double-digit royalties on net sales.
As a result of the transaction, MorphoSys increased its financial guidance for 2013. MorphoSys expects revenues of approximately € 68 million to € 72 million (previously € 48 million to € 52 million) and an EBIT of € -2 million to € +2 million (previously €-18 million to € -22 million). The original guidance did not include a successful out-licensing of any of the Company\'s proprietary development programs. Around € 20 million of the upfront payment of € 22.5 million shall be booked with signature. The remaining amount shall be distributed over 2013 and 2014 according to the development plan for the ongoing phase 1b MS trial of MOR103.
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